Trial Outcomes & Findings for Cyclophosphamide, TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive and/or Refractory Solid Malignancies (NCT NCT02224599)

NCT ID: NCT02224599

Last Updated: 2020-04-24

Results Overview

Grade, causality, start/stop dates (duration), resolutions for adverse events will be monitored and recorded.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Continuous for 45 days after the first dose.

Results posted on

2020-04-24

Participant Flow

Participant milestones

Participant milestones
Measure	CYP, TAPA-pulsed DC Vaccine, Imiquimod TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream TAPA-pulsed DC vaccine: Subjects will given the vaccine which contains 1 x 10\^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly. Cyclophosphamide Pill: Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle. Imiquimod Topical Cream: Topical Imiquimod Cream will be applied after vaccination.
Overall Study STARTED	3
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	CYP, TAPA-pulsed DC Vaccine, Imiquimod TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream TAPA-pulsed DC vaccine: Subjects will given the vaccine which contains 1 x 10\^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly. Cyclophosphamide Pill: Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle. Imiquimod Topical Cream: Topical Imiquimod Cream will be applied after vaccination.
Overall Study Physician Decision	1
Overall Study Progression of Disease	1

Baseline Characteristics

Cyclophosphamide, TAPA-Pulsed Dendritic Cell Therapy and Imiquimod in Progressive and/or Refractory Solid Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CYP, TAPA-pulsed DC Vaccine, Imiquimod n=3 Participants TAPA-Pulsed DC Vaccine Cyclophosphamide Pill Imiquimod Topical Cream TAPA-pulsed DC vaccine: Subjects will given the vaccine which contains 1 x 10\^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly. Cyclophosphamide Pill: Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle. Imiquimod Topical Cream: Topical Imiquimod Cream will be applied after vaccination.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	50.33 Years STANDARD_DEVIATION 18.55 • n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	3 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	3 participants n=93 Participants

PRIMARY outcome

Timeframe: Continuous for 45 days after the first dose.

Population: Enrollment was terminated

Grade, causality, start/stop dates (duration), resolutions for adverse events will be monitored and recorded.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days -7, 22 and 45

Population: Enrollment was teriminated.

The response of T-cells present in the peripheral blood mononuclear cells (PBMCs) population to the peptides used to pulse a patient's dendritic cell vaccine is evaluated by measuring the expression of Th1/CTL-type cytokines (IFN-γ and/or TNF-α and/or IL-17) by a standard ELI-Spot assay using 500,000 PBMCs per experimental replicate and a minimum of 3 experimental replicates for each stimulation. The results are expressed as the average number of spots obtained from the stimulation of 500,000 PBMCs

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Days -7, 22 and 45

Population: Enrollment was terminated

DTH skin test will be performed on subject's forearm or within 5 cm from the site of prior DC vaccination, if possible

Outcome measures

Outcome data not reported

Adverse Events

CYP, TAPA-pulsed DC Vaccine, Imiquimod

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

CMO and Head of Clinical Operations

Kiromic

Phone: (832) 968-4888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60